FDA insists on warning labels for OTC chlorhexidine products

anaphylaxis skin reaction

The US Food and Drug Administration (FDA) has told manufacturers of over-the-counter (OTC) antiseptic products that contain chlorhexidine gluconate to add warning labels to their products about the possibility of a serious but rare allergic reaction.

The advice from the US medicines safety regulator comes after it identified 52 cases of anaphylaxis — including two deaths — associated with chlorhexidine products being applied to the skin. The cases, which occurred between 1969 and 2015, were all serious and 26 were life threatening. They were discovered following a trawl though national adverse event reporting system databases and the medical literature.

Chlorhexidine gluconate is mainly available over the counter in products used to clean and prepare the skin before surgery and injections to reduce bacteria that can trigger skin infections. Products are typically available as solutions, washes, sponges and swabs. Chlorhexidine gluconate is also available as a mouthwash to treat gingivitis or periodontal disease.

Warnings about the possibility of serious side effects are already included in patient information for prescription medicines containing chlorhexidine gluconate.

The FDA says healthcare professionals should ask patients if they have ever had an allergic reaction to any antiseptic before recommending or prescribing a chlorhexidine gluconate product. It says alternative products, including those containing povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride or parachlorometaxylenol, can be used if previous allergy to chlorhexidine gluconate is documented or suspected.


Last updated
The Pharmaceutical Journal, PJ, February 2017, Vol 298, No 7898;298(7898):DOI:10.1211/PJ.2017.20202304

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